Victor M. Montori, MD, MSc; German Malaga, MD
In type 2 diabetes, does intensive glucose control prevent adverse outcomes more than standard glucose control?
Randomized controlled trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation [ADVANCE]).
Blinded (outcome adjudication committee).*
Median 5 years.
215 centers in 20 countries in Asia, Australasia, Europe, and North America.
11 140 patients ≥ 55 years of age (mean age 66 y, 58% men) who had type 2 diabetes and a history of or risk factors for vascular disease. Patients requiring insulin were excluded.
Intensive glucose control with gliclazide-modified release, 30 to 120 mg/d, and other nonsulfonylurea drugs as needed to achieve a target glycated hemoglobin level ≤ 6.5% (n = 5571) or standard glucose control with drugs other than gliclazide (n = 5569).
Composite of macrovascular events (nonfatal myocardial infarction or stroke, or death from cardiovascular causes) and composite of microvascular events (new or worsening nephropathy or retinopathy). Secondary outcomes included new-onset microalbuminuria and severe hypoglycemia.
95% (intention-to-treat analysis).
The Table shows results.
Compared with standard glucose control in type 2 diabetes, intensive glucose control with gliclazide and other drugs had no effect on macrovascular events, prevented new or worsening albuminuria, but led to greater hypoglycemia.
Intensive vs standard glucose control to prevent vascular events in type 2 diabetes†
†Abbreviations defined in Glossary. RRR, RRI, NNT, NNH, and CI calculated from data in article.
‡Nonfatal myocardial infarction (intensive vs standard, 2.7% vs 2.8%), nonfatal stroke (3.8% vs 3.8%), or death from cardiovascular causes (4.5% vs 5.2%).
§New or worsening nephropathy or retinopathy (6.0% vs 6.3%).
||Macroalbuminuria, doubling of serum creatinine (1.2% vs 1.1%), and renal-replacement therapy or death from renal causes (0.4% vs 0.6%).
Victor M. Montori, German Malaga. Intensive glucose control did not prevent important complications in type 2 diabetes. Ann Intern Med. 2008;149:JC3–6. doi: 10.7326/0003-4819-149-6-200809160-02006
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Published: Ann Intern Med. 2008;149(6):JC3-6.
Cardiology, Coronary Risk Factors, Diabetes, Endocrine and Metabolism.
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